CN109303577A

CN109303577A - The device for Weight reduction bracket for allowing pyloric sphincter normally to play a role

Info

Publication number: CN109303577A
Application number: CN201811366485.0A
Authority: CN
Inventors: 约翰·A·欣斯敦; 克劳德·O·克拉克; 乔纳森·鲁特; 维沙尔·沙赫
Original assignee: Boston Scientific Scimed Inc
Current assignee: Boston Scientific Scimed Inc
Priority date: 2014-09-18
Filing date: 2015-09-17
Publication date: 2019-02-05
Anticipated expiration: 2035-09-17
Also published as: EP3193780A1; JP2017527388A; CN109303577B; CA2959730A1; WO2016044660A1; US9801749B2; CN106999272A; US20160081832A1; CN106999272B; JP6542877B2

Abstract

A kind of prosthese for the normal function not interfering pyloric sphincter when being implanted in gastrointestinal tract.In some cases, which is a part as sleeve-like gastrectomy and is implanted or is implanted after sleeve-like gastrectomy.The prosthese includes: bracket with outer surface and fully covers the polymer covering of rack outer surface.Bracket includes: proximal stent flange, the proximally distally extending proximal stent section of bracket flange and the proximally distally extending expanded stent section of brace sections.

Description

The device for Weight reduction bracket for allowing pyloric sphincter normally to play a role

Cross reference to related applications

The U.S. Provisional Patent Application Serial No. 62/052,000 that the claim of this application is submitted in September in 2014 on the 18th Priority, the full content of the temporary patent application are incorporated by reference herein.

Background technique

Obesity be wherein supernumerary's body fat accumulated attend the meeting to the degree that adversely affects of health so as to cause Life expectancy reduces and/or the increased patient's condition of health problem.Body mass index (BMI), what a kind of pair of body weight was compared with height Measured value, when the BMI of people is in 25kg/m²And 30kg/m²Between when people is defined as overweight (fat early period) and when BMI is greater than 30kg/m²When be defined as obesity.Obesity is most often by excessive diet heat, lacks sports and genetic predisposition Associativity reason caused by.Fifty-fifty, obesity reduced life expectancy up to 6 to 7 years.Various diseases are suffered from obesity increase The possibility of (expiratory dyspnea, certain form of cancer and Osteoarthritis especially during heart disease, diabetes B, sleep) Property.Worldwide obesity is can mainly to prevent the cause of the death, and its incidence in adult and children gradually increases, and weighs It is considered as one of the public health problem of 21 century most serious by prestige department.The World Health Organization (WHO) estimation is complete in 2005 The world at least 400,000,000 adults (9.8%) are fat.According to the report of disease prevention and control center of the U.S. (CDC), 2007- There is 34% adult in the U.S. within 2008 and 17% children are fat.In the U.S., obesity causes every year for someone's estimation Up to 365,000 death.

Weight-reducing (or loss of weight) operation is that (BMI is greater than 40kg/m for treating serious fatness²Or BMI is greater than 35kg/m² And with comorbidity) operative treatment.The most common bariatric surgery is Roux-en-Y gastric bypass (RYGB) (Fig. 1), wherein being formed Stomach folliculus and alimentary canal loop (Roux intestinal loop) and the jejunum for being mutually butted and being docked to patient, thus around the small of part Intestines.Other bariatric surgeries can involve removal (sleeve-like gastrectomy or subsidiary 12 of a part of stomach as shown in Figure 2 The gallbladder pancreas bypass of duodenum 12 indexing).About 80% stomach is removed in the gallbladder pancreas bypass of subsidiary duodenum indexing, thus shape At thin sleeve-like stomach.Be still by the valve (pylorus) that food is discharged into small intestine and be typically connected to stomach finite part small intestine (duodenum) together.The operation is bypassed by being connected to the end of intestines close to duodenum (the gallbladder pancreas bypass) of stomach Most intestines.Loss of weight operation is effective but endangers with more, such as malnutritive and disvitaminosis, and It needs closely to monitor.The operation is usually to be used to have to be greater than 50kg/m²Body mass index people.There are about 150,000 every year Name patient receives bariatric surgery.Study for a long period of time proof, these operations cause apparent long term weight to mitigate, from extensive in diabetes 23% to 40% decline of the multiple, improvement of cardiovascular risk factors and the death rate.

Postoperative leakage occurs in about 2% to 3% bariatric surgery case according to reports, but complete thus unpractical due to reporting Quantity can be higher.For RYGBP, most of leakage is the suture along gastric pouch and occurs in gastrojejunostomy.So And leaking can also occur along the Z-line between oesophagus and stomach.Leakage is most one of dire complications after bariatric surgery, and And it is related to increased morbidity and mortality.Leakage can be handled with several modes, including parenteral alimentation and enteron aisle Drainage, various endoscopic procedures (Esophageal Stent, fixture, glue, suture) and second of the bariatric surgery in situ of rest.But these Processing mode all has defect.

Esophageal Stent has been successfully used to the leakage after processing sleeve-like gastrectomy.However, these brackets are prone to move It moves, because their shape is not suitable for the stomach geometry of the change after sleeve-like gastrectomy.Two brackets are usually used, because It is too short for bracket existing for successful treatment.

For sleeve-like gastrectomy, most leakage occurs on the top (proximal end third) in stomach sleeve portion.This is because The top is less susceptible to close and is more difficult to stitching and occurs during operation, and also empties between existing in the incisura area in stomach Intestines occur when (this leads to the pressure increase in the top in stomach sleeve portion).Fig. 3 be sleeve-like gastrectomy before stomach geometry Diagram, Fig. 4 is the diagram of the stomach geometry after sleeve-like gastrectomy.

In the case where not limiting the scope of the present disclosure, some embodiments of the disclosure set forth below it is brief general It states.The embodiment of the general introduction of the disclosure and/or other details of other embodiments can be found in following specific embodiment.

Summary of the invention

In at least one embodiment, this disclosure relates to which one kind, which is configured to, allows pyloric sphincter when prosthese is implanted The prosthese normally to play a role.

Prosthese disclosed herein may include single shelf layer and polymeric layer.The single shelf layer may include bracket, And polymeric layer may include polymeric cover.

The method for forming prosthese includes: to form the nearside including proximal stent flange, proximal stent section and expanded stent section Bracket；Form the distal stent including distal stent flange；Coated polymer material is to cover proximal end and distal stent；The company of being formed Connect section；And combinations thereof.

The method for forming prosthese may include forming connecting belt.

The method for forming nearside and/or distal stent can include: at least one bracket long filament is interleaved；Wherein interweave Including braiding, knitting and knot.

Bracket can be made of proximal stent flange, proximal stent section, expanded stent section；Wherein proximal stent section is by nearside Bracket flange is connect with expanded stent section.

Bracket can be made of proximal stent flange, proximal stent section, expanded stent section and short distal segment；Wherein nearside Proximal stent flange is connect by brace sections with expanded stent section；And short distal segment is distally extending from expanded stent section.

Bracket can include: only by polymeric cover first support interconnected and second support, the first support packet It includes proximal stent flange, the proximally distally extending proximal stent section of bracket flange and proximally brace sections is distally extending Expanded stent section；And second support includes distal stent flange.

Bracket can be by proximal stent flange, the proximally distally extending proximal stent section of bracket flange, proximally bracket The distally extending expanded stent section of section is distad prolonged from the distally extending linkage section of expanded stent section and from the linkage section The distal stent flange stretched is formed.

Prosthese can include: the bracket with outer surface, which includes proximal stent flange；Proximally bracket flange is to remote The proximal stent section that side extends；The proximally distally extending expanded stent section of brace sections；And polymeric cover.

Prosthese can include: the bracket with outer surface, which includes proximal stent flange；Proximally bracket flange is to remote The proximal stent section that side extends；The proximally distally extending expanded stent section of brace sections；Fully cover rack outer surface Polymeric cover, the polymeric cover form the outer surface of prosthese.

Prosthese limits inner cavity.Prosthese can have the longitudinal length of about 340mm to about 410mm.Prosthese can have variable-diameter.

Bracket can extend to the second end of prosthese from the first end of prosthese.Bracket can be cut by laser or be interweaved.Branch Frame can be self-expanding.Bracket can be made of bracket long filament.Bracket long filament can be composite fibre.

Proximal stent flange can have about 20mm to the about 40mm preferably about longitudinal length of 30mm.Proximal stent flange exists Its widest point can have about 20mm to the about 30mm preferably about diameter of 25mm.Proximal stent flange can include: have consistent straight First and tapered second of diameter.First can form the proximal end of proximal stent flange, and second can form nearside branch The distal end of frame flange.

Proximal stent section can have about 100mm to the about 200mm preferably about longitudinal length of 150mm.Proximal stent section can With about 10mm to the about 20mm preferably about diameter of 20mm.The diameter of proximal stent section can be consistent.

Expanded stent section can have variable-diameter.Expanded stent section can have oval in shape.The first of expanded stent section End can have the diameter less than second end.Expanded stent section can have the longitudinal direction of about 40mm to about 80mm preferably about 60mm long Degree.Expanded stent Duan Qi widest point can have about 30mm to the about 70mm preferably about diameter of 50mm.

Proximal stent flange can form proximal stent end, and expanded stent section can form distal stent end.

Bracket may include the short distal segment distally extending from expanded stent section.The short distal segment can form the remote of bracket End.Short distal segment can have about 10mm to the about 30mm preferably about longitudinal length of 20mm.Short distal segment can have about 15mm extremely The about 25mm preferably about diameter of 20mm.The diameter of short distal segment can be consistent.

Bracket may also include the linkage section distally extending from expanded stent section.The linkage section can have about 30mm to about The 70mm preferably about longitudinal length of 50mm.Linkage section can have about 15mm to the about 25mm preferably about diameter of 20mm.Connection Section can be configured and arranged to not apply radial force when prosthese is implanted or apply small radial force, so as to pyloric sphincter performance Normal function.The linkage section can be configured and arranged to radially increase when pyloric sphincter opening/closure and reduce the diameter.Connection Section can be formed by the polymeric cover of a part.Linkage section can be the linkage section of braiding.

The polymeric cover of a part can be supported by connecting belt.The connecting belt can have about 30mm to the longitudinal direction of about 70mm Length.The connecting belt can be longitudinal strut.Connecting belt can be bracket long filament.More bracket long filaments can be woven with shape At the strut connecting belt of braiding.Connecting belt can be welded to expanded stent section and be welded to distal stent flange.

Bracket may also include the distal stent flange distally extending from linkage section.Distal stent flange can have about 20mm To the about 40mm preferably longitudinal length of 30mm.Distal stent flange can have about 20mm to about 30mm preferably in its widest point The diameter of about 25mm.Distal stent flange can include: first and tapered second with consistent diameter.Second The proximal end of proximal stent flange can be formed, first can form the distal end of distal stent flange.Distal stent flange can be formed far Collateral frame end, proximal stent flange can form proximal stent end.

Bracket long filament can be woven with the first braid angle, to form proximal stent flange, proximal stent section, expand branch Frame section and distal stent flange.Bracket long filament can be woven with the second braid angle, to form the linkage section of braiding.Second Braid angle is smaller than the first braid angle.First braid angle can be about 120 °, and the second braid angle can be about 60 °.

Bracket may also include distal stent flange.Polymeric cover, which can be formed, will be enlarged by brace sections and is joined to distal stent The linkage section of flange.

Proximal stent flange sections can form proximal stent end, and distal stent flange can form distal stent end.

Bracket can include: the first support including proximal stent flange, proximal stent section and expanded stent section；Including remote The second support of side stand flange；Wherein the first and second brackets are only to be connected by the polymeric cover of a part.

Polymeric cover can fully cover the outer surface of bracket.Polymeric cover can form the outer surface of prosthese. Polymeric cover can be in a tubular form.Polymeric cover may include silicone.Polymeric cover can degradation resistant, impermeable, stifled Plug leaks, reduction tissue is grown into, and combinations thereof.Polymeric cover is fixed to bracket.Polymeric cover may include being consolidated Surely it arrives the first polymer covering of rack outer surface and is fixed to the second polymer covering of stent inner surface.Polymerization Object covering may include selected from by silicone, styrene-isoprene-styrene block copolymer (SIBS), e-PTFE second Group composed by alkene (ePTFE), polyurethane, and combinations thereof material.

Prosthese may include one layer of the therapeutic agent on polymeric cover outer surface.

Specifically the generation appended by the disclosure and constitutes in the claim of a part of this disclosure and indicate these and other Embodiment.However, can refer to the attached drawing for constituting disclosure other parts in order to be further understood from and wherein illustrate simultaneously The subsidiary description of one or more embodiments is described.

Detailed description of the invention

Fig. 1 is the schematic diagram of gastral each section after Roux-en-Y operation.

Fig. 2 is the schematic diagram of gastral each section after the gallbladder pancreas bypass of subsidiary duodenum version.

Fig. 3 is the schematic diagram in the geometry of the glandular stomach of sleeve-like gastrectomy.

Fig. 4 is the schematic diagram of the geometry of the change of stomach after sleeve-like gastrectomy.

Fig. 5 A is the schematic cross sectional views of an embodiment of prosthese.

Fig. 5 B is the schematic cross sectional views with prosthese shown in Fig. 5 A of connecting belt.

Fig. 6 is the schematic cross sectional views of an embodiment of the prosthese of the linkage section with part closure.

Fig. 7 is the schematic cross sectional views of an embodiment of prosthese.

Fig. 8 is the schematic cross sectional views of an embodiment of prosthese.

Specific embodiment

Although the theme of the disclosure can be embodied as many different forms, the tool of the disclosure is described in detail herein Body preferred embodiment.The description is the example of disclosure principle, and is not intended to for the disclosure to be confined to illustrated specific Embodiment.

For purposes of this disclosure, similar appended drawing reference should refer to similar feature in the drawings, unless otherwise saying It is bright.

Each definition is provided for term defined below.It is intended that using these definition, unless in the claims Or other places in the disclosure provide different definition.

All numerical value hypothesis can be modified by word " about " herein, regardless of whether it is manifestly intended that.Word " about " Number including being rounded up to nearest effective digital.

Using endpoint logarithm range narration include in the range it is all number (for example, 1 to 5 include 1,1.5, 2,2.75,3,3.80,4 and 5).

Term " consistent " includes variation caused during manufacture.

Singular " one " used in disclosure and the accompanying claims, "one" and "the" include that plural number is signified Object, unless the context clearly dictates otherwise.Term "or" used in disclosure and the accompanying claims is logical It is often to be used with including the meaning of "and/or", unless being clearly indicated otherwise in context.

Used term " connection " or " engagement " do not include " indirect " connection or engagement in the disclosure.

Prosthese and the element for constituting prosthese respectively have width, length and thickness.Used in the disclosure " thickness " It is to be measured from prosthese outer surface to prosthese inner surface radial direction；" width " is to measure in a circumferential direction；" length " It is to measure in a longitudinal direction.

" inner surface " of used prosthese is the surface for limiting prosthese inner cavity, the and " appearance of prosthese in the disclosure Face " is opposite with inner surface.

" covering " 14 used in the disclosure extends in the overthe openings as defined by cradle wall, and thus closing is opened Mouth simultaneously prevents the tissue growth for entering prosthese inner cavity by being open.Bracket 12, which can be, is completely covered bracket.It is used herein " bracket is completely covered " have and at least extend to the covering 14 of second end from the first end of bracket.Therefore, branch is completely covered The covering 14 of frame has the length of the length equal to or more than bracket 12." part covering bracket " used herein includes The covering 14 of longitudinal length with the longitudinal length for being less than bracket 12.

Used therapeutic agent layer or coating are not coverings 14 used herein in the disclosure.

Datum mark used in the disclosure for " nearside " and " distal side " is the mouth or starting point of gastrointestinal tract, and false " close " end of body 10 is configured to be positioned as when prosthese 10 is implanted into gastrointestinal tract " remote " end than prosthese 10 mutually closer to gastrointestinal tract Starting point.

" end " used in the disclosure is the decline or end of an element, and " petiolarea " is adjacent thereto Region and including " end ".

" area " or " portion " is second longitudinal direction position to be extended to from first longitudinal direction position and along pipe used in the disclosure The a part for the tubular prostheses 10 that the whole circumference of shape prosthese extends.

" diameter " used herein is the distance of the straight line extended between two points, and does not indicate specific shape Shape.

Detailed description below should refer to attached drawing and be read, wherein similar component in different figures is with identical Appended drawing reference indicates.Each attached drawing being not necessarily drawn to scale depicts illustrated embodiment, and is not intended to limit this public affairs The range opened.

A. prosthese

Pylorus enters duodenum by the open and closed of pyloric sphincter to adjust food from stomach.Pyloric sphincter is Bands of muscle around pyloric ostium indicates the engagement between stomach and duodenum.If making pyloric ostium that open state be maintained to make It obtains duodenum to open, then the bile regurgitation into stomach and oesophagus can occur.This will lead to sense of discomfort.Refer to compared to subsidiary 12 The gallbladder pancreas bypass of intestines indexing, bile regurgitation are more likely to occur in sleeve-like gastrectomy, because after gallbladder pancreas bypass Bile will must travel through alimentary canal loop.

Prosthese 10 disclosed herein is configured and arranged to be implanted in gastrointestinal tract.The prosthese can be conveyed from small diameter Shape is expanded into larger diameter implantation shape, just as known in the art.

Prosthese 10 disclosed herein is configured and arranged to allow pyloric sphincter normally to send out when prosthese is implanted The effect of waving (see, for example, Fig. 5 A-8).As described in more detail below, it is located in the distal end of the prosthese of implantation 10 close to deep and remote It is configured to not interfere pyloric sphincter normal in the case where door sphincter or in the section of implantation prosthese 10 across pyloric sphincter In the case where open and closed, pyloric sphincter can bring into normal play function.In some cases, prosthese 10 is cut as sleeve-like stomach It is implanted into except the part of art or after sleeve-like gastrectomy.In these cases, prosthese 10 can be described as weight-reducing prosthese.

Prosthese 10 limits inner cavity (see, for example, figure 5-8).Prosthese 10 can not have for adjusting by prosthese inner cavity The valve structure of flow (see, for example, figure 5-8).As described in this article, by the inner cavity flow can only by linkage section 22 into Row is adjusted.

Prosthese 10 disclosed herein can be self-expanding, the longitudinal length with about 340mm to about 410mm, tool There is variable-diameter, and combinations thereof.Prosthese 10 includes polymer covering and single shelf layer (see, for example, Fig. 5-Fig. 7).Prosthese 10 inner cavity can partly be limited by single shelf layer or by interpolymer covering.

A.1. the polymer covering of prosthese

The blocking of prosthese 10 leakage can be improved in the polymer covering, reduction tissue grows into (in-growth) and combinations thereof Ability.The tolerable degradation of polymer covering, can be it is permeable, and combinations thereof.

Polymer covering includes polymeric cover 14.The polymeric cover 14 covers some or all of bracket 12 Longitudinal length.Therefore, bracket 12 can be part covering bracket or bracket be completely covered.It can be in any suitable manner (such as, but not limited to dip coated or spraying coating), by coating polymeric materials to bracket 12 to form polymeric cover 14.Alternatively, polymeric cover 14 in a tubular form, and can pass through interference fit, by suturing or passing through any other Suitable fixing means is fixed to bracket 12.

Prosthese can have single polymeric layer or two polymeric layers.Polymeric cover 14 can be to form prosthese 10 The single layer (see, for example, figure 5-8) or polymeric cover of outer surface may include forming the first of prosthese outer surface to cover Cover material and the second covering for forming prosthese (not shown) inner surface.In the case where the tool of prosthese 10 is there are two polymeric layer, the One polymeric layer can cover the outer surface of shelf layer/bracket 12, and the second polymer layer can cover the interior table of shelf layer/bracket 12 Face.

Suitable material for polymeric cover 14 includes: silicone, styrene-isoprene-phenylethene block copolymerization Object (SIBS), expanded PTFE (ePTFE), polyurethane, and combinations thereof.Polymeric cover 14 can be by the material that is swollen Made by material, and/or it is coated with the reagent being swollen in situ.

A.2. the shelf layer of prosthese

Prosthese 10 has single shelf layer (see, for example, figure 5-8).The single shelf layer can be formed by bracket 12.Branch The shape of frame 12 is designed to prevent to distal end or proximal excursion.The first end and second end of the composition prosthese 10 of bracket 12.

Bracket 12 can be formed by one or more bracket long filament to interweave.The branch including braiding used herein that interweaves The bracket long filament of frame long filament, the bracket long filament of knitting and knotting.Some examples of braided support include by Boston Scientific company manufactures and sellsWithBracket.It is knitted the one of bracket A example is the Ultraflex manufactured by Boston Scientific company^TMBracket, an example of knotting bracket be by The Precision Colonic of Boston Scientific company manufacture^TMBracket.Bracket 12 can be cut by laser.It can replace Dai Di, bracket 12 can be the combination of any of above cantilever type.

Bracket 12 can convey shape from small diameter and be expanded into larger diameter implantation shape, as being known in this field 's.Bracket 12 can be self-expanding.

Suitable material for bracket long filament includes alloy, such asWithPolymer, such as poly- pair Ethylene terephthalate (PET)；Biodegradable polymers；And radiopaque material.Bracket long filament can be core fibre Or composite fibre, such as with Nitinol^TMShell and platinum core.It is disclosed in United States Patent (USP) 7,101,392 and 6,527,802 There are some examples of core fibre or composite fibre, the full content of each patent is incorporated by reference herein.

Bracket 12 includes proximal stent flange 20, proximal stent section 18 and expanded stent section 16 (such as Fig. 5 A- Fig. 8).Closely Proximal stent flange 20 is connect by side stand section 18 with expanded stent section 16.

Bracket 12 may also include the short distal segment 26 distally extending from expanded stent section 16 (see, for example, Fig. 8).This is short Distal segment 26 can be cylindrical, and has about 15mm to the consistent diameter of about 25mm preferably about 20mm and about 10mm to about The 30mm preferably about longitudinal length of 20mm.The distal end of short distal segment 26 constitutes the distal end of bracket 12.When with short distal segment 26 Prosthese 10 when being implanted, the distal end of the prosthese 10 of implantation is located in close to pyloric sphincter.

Bracket 12 may also include distal stent flange 24 (such as Fig. 5-Fig. 6).Bracket 12 shown in Fig. 5 A- Fig. 5 B can quilt It is described as including including proximal stent flange 20, proximal stent section 18, the proximal stent portion of expanded stent section 16 and including remote The distal stent portion of side stand flange 24.As described in more detail below, diameter of the expanded stent section 16 at its widest point is big In the diameter of proximal stent section 18, and it is equal to or more than nearside and distal stent flange 20,24 at their widest point Diameter.

Prosthese 10 may include that will be enlarged by linkage section 22 that brace sections 16 engage with distal stent flange 24 (such as Fig. 5-figure 6).As described in more detail below, the polymeric cover 14 that linkage section 22 can be a part (is supported by connecting belt or is not propped up Support, such as Fig. 5 A- Fig. 5 B) or braiding section (such as Fig. 6).

A.2.a. proximal stent flange

When proximal stent flange 20 is configured so that the prosthese 10 shown in such as figure 5-8 is implanted, proximal stent Flange is expanded along the wall of oesophagus distal region to prevent any food or liquid from passing through between prosthese and esophageal wall.

Proximal stent flange 20 has variable-diameter.Proximal stent flange 20 is unfolded outward, so that proximal stent flange 20 Proximal end have greater than proximal stent flange 20 distal end diameter (see, for example, figure 5-8).Proximal stent flange 20 can wrap Include first with consistent diameter and second (see, for example, figure 5-8) with reduced diameter.

Proximal stent flange 20 can have about 20mm to the about 40mm preferably about length of 30mm, and upon expansion at it Widest point has about 20mm to the about 30mm preferably about diameter of 25mm.Diameter of the proximal stent flange 20 at its widest point is big In the consistent diameter of proximal stent section (see, for example, figure 5-8).The size of proximal stent flange 20 be in order to illustrate rather than It provides for the purpose of limitation.It should be understood that can modify to the size of proximal stent flange 20 to match various dissections Structure.

A.2.b. proximal stent section

Proximally bracket flange 20 is distally extending for proximal stent section 18.Proximal stent section 18 can proximally bracket flange 20 Taper second distally extending (see, for example, figure 5-8).Proximal stent section 18 is configured so that ought be in such as figure 5-8 Shown in prosthese 10 when being implanted, proximal stent section 18 extends into the stomach of proximal end from the distal region of oesophagus, thus by Z-line bridge Even.

Proximal stent section 18 can have the consistent diameter of about 10mm to about 20mm preferably about 15mm upon expansion；With about 100mm to the about 200mm preferably about length of 150mm；And combinations thereof.The size of proximal stent section 18 be in order to illustrate rather than It provides for the purpose of limitation.It would be recognized by those skilled in the art that can modify to the size of proximal stent section 18 with Match various anatomical structures.

A.2.c. expanded stent section

Proximally brace sections 18 are distally extending for expanded stent section 16.Expanded stent section 16 is configured so that ought such as Fig. 5- When prosthese 10 shown in fig. 8 is implanted, expanded stent section 16 is located in the antrum being transformed by bariatric surgery.Expanded stent Section 16 can cooperate with proximal stent flange 20, to prevent the distally and proximally offset of prosthese 10.

Expanded stent section 16 has variable-diameter upon expansion (see, for example, figure 5-8).Expanded stent section 16 can be in ovum Circular shape, wherein the first end of expanded stent section 16 has the diameter less than second end (see, for example, figure 5-8).Expand branch Frame section 16 can have about 40mm to the about 80mm preferably about length of 60mm, and have about at its widest point upon expansion 30mm to the about 70mm preferably about diameter of 50mm.Diameter of the expanded stent section 16 at its widest point is greater than proximal stent flange 20 diameters at its widest point and the consistent diameter greater than proximal stent section 18 (see, for example, figure 5-8).Expanded stent section 16 size is in order to illustrate providing rather than the purpose for limitation.It would be recognized by those skilled in the art that can be to expansion The size of brace sections 16 is modified to match various anatomical structures.

A.2.d. linkage section

Linkage section 22 is configured and arranged to when prosthese is implanted across pyloric sphincter.Therefore, linkage section 22 can be claimed For the pyloric sphincter section of prosthese.It is false when linkage section 22 is configured so that the prosthese 10 shown in such as Fig. 5-Fig. 6 is implanted Body 10 does not interfere the open and closed of pyloric sphincter.For example, linkage section 22 can be configured and arranged to apply small radial force or Person does not apply radial force, and/or is configured and arranged to radially increase and reduce when pyloric sphincter opening/closure straight Thus diameter allows the pyloric sphincter when prosthese 10 is implanted normally open and closed.Increase and reduce in linkage section 22 and is straight In the case where diameter, the flow of the inner cavity by prosthese 10 can be adjusted.

Linkage section 22 is distally extending from expanded stent section 16, and will be enlarged by brace sections 16 and connect with distal stent flange 24 It closes (see, for example, Fig. 5-Fig. 6).Therefore, bracket 12 have proximal stent flange 20, proximal stent section 18, expanded stent section 16, Linkage section 22 and distal stent flange 24.

Linkage section 22 can be by a part (see, for example, Fig. 5 A) of polymeric cover 14, connecting belt 30 (see, for example, figure 5B), weave section (see, for example, Fig. 6), and combinations thereof constituted.Linkage section 22 can have about 30mm to about 70mm preferably about The length of 50mm, and there is about 15mm to the about 25mm preferably about diameter of 20mm upon expansion.The diameter of linkage section 22 can To be consistent.The diameter of linkage section 22 is smaller than the diameter at expanded stent Duan Qi widest point (see, for example, Fig. 5-Fig. 6). The size of linkage section 22 be in order to illustrate rather than limitation purpose and provide.It would be recognized by those skilled in the art that can be to even The size for connecing section 22 is modified to match various anatomical structures.

Some non-selective examples of connecting belt 30 include longitudinal strut, suture, and combinations thereof.The connecting belt 30 can be The element separated with bracket long filament, or can be made of one or more bracket long filament.The quantity of connecting belt should not interfere with vacation The normal function of pyloric sphincter when body is implanted.Linkage section can have one, two, three or four connecting belt 30.? There are in the case where multiple connecting belts 30, these connecting belts can be circumferentially spaced and be longitudinally extended.Connecting belt 30 can have about 30mm to the about 70mm preferably about length of 50mm.

Polymeric cover extends in the overthe openings as defined by circumferentially-adjacent connecting belt.Therefore, material will not be through It crosses and is open and inflow/outflow prosthese inner cavity as defined by circumferentially-adjacent connecting belt.Therefore, prosthese 10 is not configured and arranged to It is implanted in the crotch of two blood vessels.

In the case where connecting belt is the element separated with bracket long filament, connecting belt can be fixed in any suitable manner To nearside and distal stent.For example, may be welded to proximal end and distal stent.

In the case where one or more bracket long filament constitutes connecting belt, bracket long filament can be woven to form braiding Strut is formed as non-woven multifilament strut.The connecting belt of this type is referred to alternatively as " integrated connecting belt " because it be by It is constituted with same root (more) the bracket long filament for constituting proximal stent and/or distal stent.

Linkage section 22 be braiding section in the case where, the braiding section be by the low-down braid angle with about 30 ° to 90 ° and The bracket long filament of braiding is constituted.Low braiding angle has low radial force, and has lesser shortening compared with larger braid angle. If will only extend 7mm for example, the 20mm diameter linkage section with 60 ° of braid angles is compressed to the diameter of 6mm.It is radial The case where pressure will be 120 ° than braid angle is about 5 times low.

The bracket long filament for constituting braiding linkage section 22 also may make up proximal stent flange 20, proximal stent section 18, expand branch Frame section 16 and distal stent flange 24.In this embodiment, bracket long filament is carried out with about 100 ° to about 140 ° of braid angle Braiding, and form proximal stent flange 20, proximal stent section 18, expanded stent section 16 and distal stent flange 24.

Alternatively, to proximal stent flange 20, proximal stent section 18, expanded stent section 16 and distal stent flange In the case that 24 are cut by laser, braiding linkage section 22 can be attached to expanded stent section 16 in an appropriate manner and be attached To distal stent flange 24.

A.2.e. distal stent flange

Distal stent flange 24 is distally extending (see, for example, Fig. 5-Fig. 6) from linkage section 22.24 structure of distal stent flange It causes so that when prosthese 10 is implanted, distal stent flange 24 is expanded along the wall of jejunum, to prevent any food or liquid in vacation Pass through between body and intestinal wall.

Distal stent flange 24 is unfolded outward, so that the distal end of distal stent flange 24, which has, is greater than distal stent flange 24 Proximal end diameter (see, for example, Fig. 5-Fig. 6).Distal stent flange 24 may include having first of reduced diameter and having Second (see, for example, Fig. 5-Fig. 6) of consistent diameter.Second of distal stent flange 24 may make up the distal end of bracket 12.

The length of distal stent flange 24 can be about 20mm to about 40mm preferably about 30mm, and upon expansion its most Width point has about 20mm to the about 30mm preferably about diameter of 25mm.Distal stent flange 24 is greater than in the diameter of its widest point and connects Connect the diameter of section 22 (see, for example, Fig. 5-Fig. 6).The size of distal stent flange 24 be in order to illustrate rather than limitation purpose And it provides.It would be recognized by those skilled in the art that can modify to the size of distal stent flange 24 to match various dissections Structure.

A.3. other optional features of prosthese

Prosthese 10 may include can be by imaging modality (such as X-ray, magnetic resonance imaging (MRI), ultrasonic wave, etc.) detection One or more regions, band, coating, component etc..In some embodiments, it is impermeable to be at least part at least part of bracket Ray.

Prosthese 10 may also include one or more mechanisms for delivering therapeutic agents.Therapeutic agent usually uses and is placed in prosthese The form of coating or one or more layers other material in surface district, the coating or layer be suitable for Using prosthesis position or Region adjacent thereto is released.

Therapeutic agent can be drug or other medical products, such as non-genomic preparation, gene formulations, cell material etc..It closes Some examples of suitable non-genomic therapeutic agent include but is not limited to: anticoagulant (such as heparin, heparin derivatives), vascular cell Growth promoter, growth factor receptor inhibitors, taxol etc..In the case where medicament includes gene formulations, this gene formulations can Including but not limited to: DNA, RNA and their own derivative and/or ingredient；Hedgelog protein etc..It include cell material in therapeutic agent In the case where material, which be may include but be not limited to: not derive from from people and/or the cell and each of people Ingredient and/or its derivative.In the case where therapeutic agent includes polymer agent, which can be polystyrene-poly Isobutene-polystyrene triblock copolymer (SIBS), polyethylene glycol oxide, silicon rubber and/or any other suitable substrate.

A.4. embodiment

The example of prosthese 10 as described above is provided in the following non-limiting examples.

Embodiment 1

Fig. 5 A shows the first embodiment of the prosthese 10 with single shelf layer.The prosthese 10, which has, fully to be polymerize The bracket 12 that object covering 14 is covered.The outer surface of the formation prosthese 10 of polymeric cover 14.Prosthese as shown in Figure 5 A 10 can be implanted after sleeve-like gastrectomy.

Bracket 12 has proximal stent flange 20, proximal stent section 18, expanded stent section 16 and distal stent flange 24. Proximal stent flange 20 limits the proximal end of bracket, and distal stent flange 24 limits the distal end of bracket 12.

Nearside and distal stent flange 20,24 flaring outs.The proximal end of proximal stent flange 20 has greater than its distal end Diameter.The distal end of distal stent flange 24 has the diameter greater than its proximal end.

Proximal stent flange 20, proximal stent section 18 and expanded stent section 16 constitute proximal stent, distal stent flange 24 Constitute distal stent.Proximal stent has total longitudinal length of about 240mm, and wherein proximal stent flange 20 has the length of about 30mm Degree, proximal stent section 18 have the length of about 150mm, and expanded stent section 16 has the length of about 60mm.Distal stent has about The longitudinal length of 30mm.

Polymeric cover 14 is the outer surface for being made of silicone, and forming prosthese 10.

Linkage section 22 is formed by the tubular sections of polymeric cover 14.Linkage section 22 has the longitudinal length of about 50mm The diameter of about 20mm.Linkage section 22 will be enlarged by brace sections 16 and engage with distal stent flange 24.

When the prosthese 10 shown in Fig. 5 A is implanted in gastrointestinal tract, the proximally-located of prosthese 10 is in oesophagus；Prosthese 10 Distal end be positioned in the duodenum in pyloric sphincter distal side；The proximally-located of linkage section 22 is in close to pyloric sphincter； The distal end of linkage section 22 is positioned in the duodenum in pyloric sphincter distal side.Linkage section 22 is configured and arranged to apply small Radial force does not apply radial force, and/or radially increases and reduce the diameter when pyloric sphincter opening/closure, Thus allow pyloric sphincter normally open and closed when prosthese 10 is implanted.

Embodiment 2

Fig. 5 B shows the second embodiment of the prosthese 10 with single shelf layer.The prosthese 10, which has, fully to be polymerize The bracket 12 that object covering 14 is covered.The outer surface of the formation prosthese 10 of polymeric cover 14.Prosthese as shown in Figure 5 B 10 can be implanted after sleeve-like gastrectomy.

Proximal stent flange 20, proximal stent section 18 and expanded stent section 16 form proximal stent, distal stent flange 24 Form distal stent.Proximal stent has total longitudinal length of about 240mm, and wherein proximal stent flange 20 has the length of about 30mm Degree, proximal stent section 18 have the length of about 150mm, and expanded stent section 16 has the length of about 60mm.Distal stent has about The longitudinal length of 30mm.

Linkage section 22 has the longitudinal length of about 50mm and the diameter of about 20mm.Linkage section 22 will be enlarged by brace sections 16 and remote Side stand flange 24 connects.Linkage section 22 includes the tubular portion and connecting belt 30 of polymeric cover 14.As described above, connecting belt 30 may is that independent element or are made of bracket long filament；Non-woven strut or braiding strut；And combinations thereof.

When the prosthese 10 shown in Fig. 5 B is implanted gastrointestinal tract, the proximally-located of prosthese 10 is in oesophagus；Prosthese 10 Distal end is positioned in the duodenum in pyloric sphincter distal side；The proximally-located of linkage section 22 is in close to pyloric sphincter；Even The distal end for connecing section 22 is positioned in the duodenum in pyloric sphincter distal side.With and without 22 structure of linkage section of connecting belt 30 It makes and is arranged to apply small radial force or does not apply radial force, and/or radially when pyloric sphincter opening/closure Increase and reduce the diameter, thus allows pyloric sphincter normally open and closed when prosthese 10 is implanted.

Embodiment 3

The 3rd embodiment of prosthese 10 with single shelf layer is shown in Fig. 6.The prosthese 10 has bracket 12 and polymerization Object covering 14.The outer surface of the polymeric cover 14 formation prosthese 10.Prosthese 10 as shown in Figure 6 can be cut in sleeve-like stomach Except art is implanted later.

Bracket 12 has proximal stent flange 20, proximal stent section 18, big brace sections 16, braiding linkage section 22 and distal side Bracket flange 24.Fig. 6 shows the braiding linkage section 22 in part closure/contraction state.

Nearside and distal stent flange 20,24 are unfolded outward.The proximal end of proximal stent flange 20 has greater than its distal end Diameter.The distal end of distal stent flange 24 has the diameter greater than its proximal end.

Bracket 12 has total longitudinal length of about 310mm, and proximal stent flange 20 has about 30mm in its widest point Length and about 30mm diameter；Proximal stent section 18 has the length diameter consistent with about 15mm's of about 150mm；Expanded stent 16 length with about 60mm of section and the diameter at its widest point with about 50mm；Linkage section 22 is woven with about 57mm's Shrink the expansion implanted diameter of implantation length, expansion the implantation length and about 20mm for shrinking implanted diameter, about 50mm of about 6mm； And distal stent flange 24 has the length of about 20mm and the diameter of the 20mm at its widest point.Constitute braiding linkage section 22 The braid angle of bracket long filament be about 60 °；Proximal stent flange 20, proximal stent section 18,16 and of expanded stent section are constituted simultaneously The braid angle of the bracket long filament of distal stent flange 24 is about 120 °.

When the prosthese 10 shown in Fig. 6 is implanted gastrointestinal tract, the proximally-located of prosthese 10 in oesophagus, prosthese 10 it is remote End is positioned in the duodenum in pyloric sphincter distal side；The proximally-located of linkage section 22 is woven in close to pyloric sphincter； The distal end of braiding linkage section 22 is positioned in the duodenum in pyloric sphincter distal side.Braiding linkage section 22 is configured and arranged to Apply small radial force or do not apply radial force, and/or radially increases and reduce when pyloric sphincter opening/closure Thus diameter allows pyloric sphincter normally open and closed when prosthese 10 is implanted.

Embodiment 4

The fourth embodiment of prosthese 10 with single shelf layer is shown in Fig. 7.The prosthese has bracket 12 and polymer Covering 14.The outer surface of the polymeric cover 14 formation prosthese 10.Prosthese 10 in as shown in Figure 7 can be in sleeve-like pacing stomach It is implanted after art.Prosthese 10 has the longitudinal length of about 240mm.

Bracket 12 has proximal stent flange 20, proximal stent section 18 and expanded stent section 16.Proximal stent flange 20 to Outer expansion, so that the proximal end of proximal stent flange 20 has the diameter greater than its distal end.Bracket 12 has total longitudinal direction of about 240mm Length, and proximal stent flange 20 has the length of about 30mm and the diameter of the about 30mm at its widest point；Proximal stent Length of the section 18 with about 150mm is simultaneously cylindrical, has the consistent diameter of about 15mm；Expanded stent section 16 is with about 60mm's The diameter of length and the about 50mm at its widest point.

Bracket 12 shown in fig. 7 may also include from the distally extending short distal segment 26 of expanded stent section 16 (referring to example Such as Fig. 8).Short distal segment 26 in a tubular form, and can have the consistent diameter for the consistent diameter for being equal to proximal stent section 18 (referring to example Such as Fig. 8).

When prosthese 10 shown in fig. 7 is implanted gastrointestinal tract, the proximally-located of prosthese 10 in oesophagus, prosthese 10 it is remote It holds in the stomach being positioned at close at pyloric sphincter.Therefore, when prosthese 10 is implanted, pyloric sphincter can be played normally Effect.

B. the method manufactured

The method for forming the prosthese 10 including bracket 12 and polymeric cover 14, as shown in Fig. 5 A-B, including one Or multiple following steps: the nearside branch including proximal stent flange 20, proximal stent section 18 and expanded stent section 16 is formed Frame；Form the distal stent including distal stent flange 24；Coated polymer material is to cover proximal end and distal stent and be formed Linkage section 22；Form connecting belt；It wherein forms proximal end and/or distal stent includes being interleaved to bracket long filament；Wherein interweave Including braiding, braiding and knot；Wherein the proximal end of proximal stent flange 20 has the diameter greater than distal end；Wherein proximal stent Section 18 has consistent diameter；Wherein expanded stent section has oval in shape；Wherein the proximal end of distal stent flange 24 has Less than the diameter of the distal end of distal stent flange 24；Wherein connecting belt is made of bracket long filament；Wherein bracket long filament is more Root bracket long filament；Wherein more bracket long filaments are woven, to form the strut connecting belt of braiding；Wherein connecting belt is independent Element and be fixed to proximal end and distal stent；And combinations thereof.

Nearside and distal stent can be produced on two different braiding plugs and are subsequently placed on coating plug, to incite somebody to action To form prosthese 10 and linkage section 22 on coating polymeric materials to bracket 12.It alternatively, can be by proximal end and distal stent It is produced on plug, which is also used for coating polymeric materials on bracket 12 forming prosthese 10 and linkage section 22. Any suitable plug or braiding plug can be used.

In the case where connecting belt 30 is constituted by bracket long filament, braiding plug can have the part with longitudinal groove, The longitudinal groove is for placing bracket long filament to form connecting belt.Thus, for example braiding plug can be included and is used to form closely First plug portion of side stand；Band extends into the second plug portion of the machine-direction oriented groove of outer mandrel surface；Be used to form The third plug portion of distal stent.Therefore, the first plug cage structure and arrange be shaped to proximal stent flange 20, proximal stent section 18 and expanded stent section 16；Second plug cage structure and arrange be shaped to linkage section 22；Third plug cage structure simultaneously arranges forming At distal stent flange 24.

The method for forming the prosthese 10 including bracket 12 and polymeric cover 14, as shown in Figure 6, including one or more A following steps: the bracket including proximal stent flange 20, proximal stent section 18, expanded stent section 16 is formed；Braiding connection Section 22；With distal stent flange 24；Coated polymer is to cover bracket 12；It wherein forms proximal end and/or distal stent includes pair Bracket long filament is interleaved；Wherein interweave includes braiding, braiding and knotting；The proximal end of its middle-end bracket flange 20, which has, to be greater than The diameter of distal end；Wherein proximal stent section 18 has consistent diameter；Its middle connecting segment 22 is cylindrical；Wherein to bracket long filament It is woven, and the braid angle of the bracket long filament for constituting linkage section 22 is less than other sections for constituting bracket 12 16, the braid angle of 18,20,24 bracket long filament；Wherein bracket long filament is woven, and the branch for constituting linkage section 22 The braid angle of frame long filament is about 60 °；Wherein bracket long filament is woven, and other sections 16 for constituting bracket 12,18, 20, the braid angle of 24 bracket long filament is about 120 °；Wherein the proximal end of distal stent flange 24, which has, is less than distal stent flange The diameter of 24 distal end；And combinations thereof.

Braiding plug for being woven to bracket, as shown in Figure 6, can include for first angle to bracket The first plug portion that long filament is woven；Bracket long filament woven for the second angle to be less than first angle Second plug portion；With the third plug portion for being woven with first angle to bracket long filament；Wherein first angle is about 100 ° to about 140 ° and second angle is about 30 ° to about 90 °；Wherein the first plug cage structure and arrange be shaped to proximal stent Flange 20, proximal stent section 18 and expanded stent section 16；Wherein the second plug cage structure and arrangement are shaped to braiding linkage section 22；Wherein third plug cage structure and arrange be shaped to distal stent flange 24；And combinations thereof.

The method for forming the prosthese 10 including bracket 12 and polymeric cover 14, as shown in Figure 7, including one or more A following steps: the bracket 12 including proximal stent flange 20, proximal stent section 18 and expanded stent section 16 is formed；Coating Polymer is to cover bracket 12；It wherein forms proximal end and/or distal stent includes being interleaved to bracket long filament；Wherein interleaved packet It includes braiding, braiding and knots；Wherein the proximal end of proximal stent flange 20 has the diameter greater than distal end；Wherein proximal stent section 18 is cylindrical；And combinations thereof.The example for the plug that can be used for weaving bracket as shown in Figure 7 is disclosed in commonly assigned US2011/0307070 in, entire contents are incorporated by reference herein.

C. the method used

Prosthese 10 described herein can be used for handling the leakage after bariatric surgery, and this method includes one or more Following steps: arrangement prosthese, wherein the proximally-located of prosthese is in oesophagus, and to be positioned at pyloric sphincter close for the distal end of prosthese Side or distal side in pyloric sphincter；Wherein prosthese is configured and arranged to apply small radial force or does not apply radial force, and And/or person radially increaseds or decreases diameter when pyloric sphincter opening/closure, thus allows to imprison when prosthese 10 is implanted Door sphincter is normally open and closed；Wherein prosthese includes bracket 12 and polymeric cover 14,14 shape of polymeric cover At the outer surface of prosthese；Wherein bracket 12 includes proximal stent flange 20, proximal stent section 18 and expanded stent section 16, limits The expanded stent section of prosthese distal end；Wherein bracket 12 include proximal stent flange 20, proximal stent section 18, expanded stent section 16, The linkage section 22 of braiding and the braided support of distal stent flange 24, weave bracket long filament with first angle and are formed Weave linkage section 22；Wherein bracket long filament is woven with the second braid angle and forms proximal stent flange 20, proximal stent The distal stent flange 24 of section 18, expanded stent section 16 and braiding, the second braid angle are greater than the first braid angle；Wherein first compile Knitting angle is about 100 ° to about 140 °, and the second braid angle is about 30 ° to about 90 °；Wherein bracket 12 forms the internal layer of prosthese 10 And the outer layer of the formation prosthese 10 of polymeric cover 14；And combinations thereof.

It is that above disclosure is intended to be illustrative and not be exhaustive.The description will give those skilled in the art Prompt many modifications and substitution.It as needed, can be to shown in each independent attached drawing and various elements described above It is combined or modifies to combine.All these substitutions and modification are intended that and are included within the scope of the claims, Middle term " includes " indicates " including but not limited to ".

Claims

1. a kind of prosthese, comprising:

Bracket with outer surface, the bracket include:

Proximal stent flange；

The proximal stent section distally extending from the proximal stent flange；

The expanded stent section distally extending from the proximal stent section；

The polymeric cover of the outer surface of the bracket is fully covered, the polymeric cover forms the outer of the prosthese Surface；

Distal stent flange, and

The linkage section that the expanded stent section is connect with the distal stent flange, the linkage section is by least one connecting belt It is formed or is formed by braiding section, the linkage section is configured and arranged to not apply or apply when the prosthese is implanted very small Radial force normally function so as to pyloric sphincter.

2. prosthese as described in claim 1, wherein the linkage section is made of at least one connecting belt.

3. prosthese as claimed in claim 2, longitudinal extend and circumferentially wherein at least one connecting belt includes more The connecting belt at interval.

4. prosthese as claimed in claim 3, wherein the polymeric cover is by the connection zone boundary being circumferentially spaced Extend in the opening made.

5. prosthese as described in claim 1, wherein the bracket includes bracket long filament, the bracket long filament is with the first braid angle It weaves to form the proximal stent flange, the proximal stent section, the expanded stent section and the distal stent flange, The bracket long filament also forms the connecting belt or braiding section.

6. prosthese as claimed in claim 5, wherein first braid angle is about 120 °.

7. prosthese as claimed in claim 6, wherein the linkage section is the braiding section formed by the bracket long filament, the volume Section is knitted to weave with 30 ° -90 ° of the second braid angle.

8. prosthese as claimed in claim 11, wherein

Longitudinal length of the proximal stent flange with about 20mm to about 40mm and the about 20mm at its widest point are to about The diameter of 30mm；

The proximal stent section has the longitudinal length of about 100mm to about 200mm and the consistent diameter of about 10mm to about 20mm； And

Longitudinal length of the expanded stent section with about 40mm to about 80mm and the about 30mm to about 70mm at its widest point Diameter.

9. prosthese as claimed in claim 8, wherein longitudinal length of the distal stent flange with about 20mm to about 40mm, With the diameter of the about 20mm to about 30mm at its widest point.

10. prosthese as claimed in claim 9, wherein longitudinal length and expansion of the linkage section with about 30mm to about 70mm The diameter of Zhang Shiyue 15mm to about 25mm.